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FDA 510(k)

QLAB Advanced Quantification Software 13

K-Number: K190913 · 2019-06-18

ApplicantPhilips Health Care
Decision Date2019-06-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QLAB Advanced Quantification Software 13 is a medical device manufactured by Philips Health Care. It received FDA 510(k) clearance on 2019-06-18 under approval number K190913. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QLAB Advanced Quantification Software 13?

QLAB Advanced Quantification Software 13 is a medical device that received FDA 510(k) clearance on 2019-06-18. It is manufactured by Philips Health Care. The 510(k) number is K190913.

When was QLAB Advanced Quantification Software 13 approved by the FDA?

QLAB Advanced Quantification Software 13 received FDA 510(k) clearance on 2019-06-18, under approval number K190913.

What company makes QLAB Advanced Quantification Software 13?

QLAB Advanced Quantification Software 13 is manufactured by Philips Health Care.

What is the FDA product code for QLAB Advanced Quantification Software 13?

The FDA product code for QLAB Advanced Quantification Software 13 is LLZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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